臺灣口服複方兒童製劑之合理性及門診處方型態分析

Rationality of Commercial Oral Multiple-Active Ingredients Medications and Outpatient Prescription Patterns for Children in Taiwan

陳彥汝(Yen-Ju Chen)

指導教授 ： 林慧玲

國立臺灣大學/醫學院/臨床藥學研究所/碩士(2010年)

https://doi.org/10.6342/NTU.2010.00719

摘要

研究背景
增加適合的兒童製劑與促進兒童用藥安全為各國推動之目標，台灣兒童用之藥品不乏複方製劑，然而目前尚未了解台灣全民健保給付之複方藥品中適合兒童使用的比例，與這些複方製劑實際開方情形。
研究目的
了解台灣現有健保給付之口服複方製劑中，符合理想兒童的複方製劑及比例；利用健保資料庫，調查台灣兒童門診開立複方製劑之處方型態，及合理口服複方兒童製劑實際使用情形。
研究材料與方法
研究材料為2009年7月公布之全民健保用藥品項資料中口服複方製劑部分，與2005年至2008年全民健保資料庫基本資料檔及百萬承保抽樣歸人檔。
依複方製劑是否有兒童適應症與兒童使用劑量資訊、成分含量是否適合兒童使用、劑型是否方便兒童使用、重複藥理機轉及成分含量比例，來篩選出適合未滿12歲兒童使用之複方製劑，再依適用年齡分組為未滿6歲及6歲至未滿12歲，討論這些適合複方製劑之組成與特性。
以健保資料庫中未滿12歲兒童門診就醫資料，分析含複方製劑之處方型態，包括兒童就醫之醫療院所特約別、開立處方的地區與分局別、就醫科別分布、就醫之診斷與開方複方製劑之藥理分布；計算適合兒童使用之複方製劑開方筆數與在各醫院醫療層級、開立藥品所屬各分局別與各開方科別的開方比例；以SAS軟體進行迴歸分析，探討哪些因素可能影響複方製劑的開立，與影響合理的複方兒童製劑的開立。
研究結果
2009年7月健保給付之用藥品項中，共有1348筆複方藥品，包括219種學名核價主成分及23種劑型。其中適合兒童使用之複方製劑共有317筆（23.5%），包含無劑量資訊但經臨床判斷兒童可使用的有21筆（1.6%）、適合未滿6歲兒童使用之複方兒童製劑有205筆（15.2%）。所有適合兒童使用之複方製劑中，參考文獻資料較完整的西方典籍劑量資訊篩選出的只有130筆，佔所有複方製劑之9.6%。這些複方兒童製劑藥理分類最多的依序為腸胃道及代謝（35.5%）、感染（28.0%）與呼吸系統（20.6%）；而各藥理分類中合理複方兒童製劑佔所有複方製劑的比例以感染（79.1%）最高，在全身性荷爾蒙、腫瘤及免疫調節與感覺系統類則沒有任何適合兒童使用之複方製劑。
健保資料庫未滿12歲兒童的門診就醫處方資料中，有9成的處方箋是由基層院所開立，而在所有含口服藥品處方中約有55%~60%處方含有至少一個（含）複方製劑；開方複方製劑主要藥理類別分布有7成以上是呼吸系統類；就醫診斷也是以呼吸道疾病為主。而適合兒童使用之複方製劑佔所有複方製劑開方次數比例，就醫年齡未滿6歲之兒童平均開方比例為11.2%（醫學中心、區域醫院、地區醫院、基層院所各為10.9%、13.4%、11.0%、11.1%）；就醫年齡6歲至未滿12歲之兒童平均開方比例為10.3% （醫學中心、區域醫院、地區醫院、基層院所各為12.4%、12.7%、9.2%、10.2%），而最常開方之合理複方製劑藥理分類，則是腸胃道及代謝為最高（87.4%），呼吸系統只佔2.4%；各藥理分類中適合兒童使用的複方製劑開方比例，則是以其他類（100%）與腸胃道及代謝（55.4%）最高，而呼吸系統中只佔（0.3%）。
結論
本研究為台灣地區第一個針對兒童使用口服複方製劑情形與其門診開方型態的研究。台灣至2009年7月健保給付的口服藥品中，適合未滿12歲兒童使用之合理複方兒童製劑佔所有複方製劑之23.5%，但真正參考西方文獻資料完整的只佔9.6%；而在健保資料庫中兒童門診處方資料中，適合兒童使用的複方製劑開方次數只佔所有開方複方製劑之10.3%~11.2%，在基層院所中開立未滿6歲理想製劑更只有2.2%，表示兒童使用到複方製劑有相當的比例並不適當，尤其以呼吸道系統問題最多。

關鍵字

兒童 ； 複方製劑 ； 全民健康保險 ； 門診處方型態 ； 台灣

並列摘要

Background
Improving pediatric drug safety and increasing the number of pediatric formulations are important issues all over the world. In Taiwan, there are many multiple- active ingredients medications for children. The appropriate and the utilization of these multiple-active ingredients medications in children are unknown.
Objective
To understand the availability and appropriateness of multiple-active ingredients medications for children as well as their prescribing pattern for pediatric outpatients in Taiwan.
Materials and Methods
The drug database we used was the drug formulary issued by the Bureau of National Health Insurance (NHI) in July, 2009. The outpatient prescriptions were obtained from the longitudinal database and registration datasets from the National Health Insurance Research Database between 2005 and 2008.
The criteria to evaluate the appropriateness of multiple- active ingredients medications for children younger than 12 years include: indications, dosing information of active ingredients for children, unit contents, dosage form, and therapeutic duplications of the active ingredients and dosing ratio. The appropriate for children were divided into those for children younger than 6 y/o and those for children 6-12 y/o. We analyzed the outpatient prescriptions for children younger than 12 y/o which contain at least one multiple- active ingredients medications. The utilization of multiple- active ingredients medications in different clinical setting, medical divisions and diagnosis were analyzed. We used SAS (version 9.1.3 SAS Institute Inc., Cary, NC, U.S.A.) to do multiple regression to explore the influence factors.
Results
Of the NHI formulary, there are 1348 oral multiple- active ingredients medications were included in the study. These included 219 major active ingredients and 23 dosage forms. The percentage of multiple- active ingredients medications appropriateness for children younger than 12 y/o is 23.5% (317), including 21 (1.6%) considered suitable for children without pediatric dosage information. Among them, there were 205 (15.2%) were suitable for children younger than 6 y/o. Only 130 (9.6%) of all the multiple- active ingredients medications met all the criteria of an ideal pediatric. The most common proportion suitable for children were agents for alimentary tract and metabolism (35.5%), antiinfectives (28.0%) and respiratory system (20.6%). Systemic hormonal preparations, excl. Sex hormones and insulins, antineoplastic and immunomodulating agent, and sensory organs had no suitable multiple- active ingredients medications for children.
About 90% of the prescriptions for children younger than 12 y/o were prescribed in primary care clinics, and there were 55%~60% prescriptions contained at least one multiple- active ingredients medications. The major diagnoses for children were diseases of respiratory system. The most often prescribed medications were those used for respiratory system (70%). The utilization of appropriate multiple- active ingredients medications were 11.2% in children younger than 6 y/o, and 10.3% in children between 6 and 12 y/o. Of the multiple- active ingredients prescriptions, 87.4%of drugs for alimentary tract and metabolism were preparations appropriate for children, while only 0.3% prescription of drugs for respiratory system were appropriate.
Conclusions
About 23.5% of multiple- active ingredients medications can be used in children younger than 12 y/o, only 9.6% are ideal pediatric dosage forms. Only 10.3%~11.2% of the multiple- active ingredients medications were preparation suitable for children. In primary care clinics, only 2.2% of the multiple- active ingredients medications prescription ideal pediatric dosage forms. Most children received multiple- active ingredients medications with inappropriate components, doses, or dosage forms, especially drugs for respiratory diseases.

並列關鍵字

Child ； National Health Insurance ； Outpatients ； Prescriptions ； Taiwan

參考文獻

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